Medical Outcomes Short-Form Health Survey

Link to instrument: http://www.sf-36.org

Acronym:

SF-36

Purpose:

The SF-36 is a generic patient-reported outcome measure aimed at quantifying health status, and is often used as a measure of health-related quality of life.

Description:

The SF-36 is a 36-item questionnaire that measures the physical and mental health constructs of health status. These constructs are measured through 8 subscales. The physical component (PCS) is made up of physical functioning (PF), role-physical (RP), bodily pain (BP), and general health (GH). The Mental component (MCS) is made up of vitality (VT), social functioning (SF), role-emotional (RE), and mental health (ME). Each of the 36 items is answered using a Likert-type scale and a 4-week recall period, with a total score of 0-100 possible. A higher score indicates better health status.

The SF-36 has been translated for over 50 different countries. The SF-36 can be a self- or computer-administered, or provided in an interview format in persons or over the phone for patients over the age of 14.

Area of Assessment: Activities of Daily Living

ICF Domain: Body Structure, Body Function, Activity, Participation

Domain: ADL, General Health

Assessment Type: Patient Reported Outcomes

Length of Test: 06 to 30 Minutes

Time to Administer:

5-10 minutes

Number of Items: 36

Equipment Required:

None

Training Required:

None

Type of training required: No Training

Cost: Not Free

Actual Cost:

Age Range: Adult: 18-64 years, Elderly adult: 65+

Populations Tested:

• Cancer of the head and neck

Standard Error of Measurement (SEM):

Minimal Detectable Change (MDC):

Minimally Clinically Important Difference (MCID):

Cut-Off Scores:

Normative Data:

Previously untreated, primary HNC:

 

(Funk G.F., Karnell L.H., Dawson C.J., et al, 1997; n = 180, mean age 58.9 (range, 20-85))

 

	US Norms	95% CI	HNC Pre-Surgery	95% CI
45-64 years (n = 39)
PCS	49.64	49.58-49.70	42.64	39.00-46.28
MCS	50.53	50.47-50.59	41.97	38.25-45.69
55-64 years (n = 51)
PCS	45.90	45.82-45.98	43.82	40.94-46.70
MCS	51.05	50.98-51.12	44.68	41.52-47.84
65-74 years (n = 48)
PCS	43.33	43.28-43.38	42.33	39.05-45.61
MCS	52.68	52.54-52.72	49.87	46.88-52.86

 

	HND pre-surgery(n=180)	SC	HNC, 6 months post-surgery (n=109)	SD	P-value
PCS	43.61	11.49	42.88	10.61	0.0470
MCS	45.05	11.97	47.19	11.82	0.1463

 

General Population:

 

(Ware J.E., Kosinski M., Keller S.D., 1994)

• General population mean for SF-36 component scores (not specific to head and neck cancer) = 50 (SD, 10)

Test-retest Reliability:

Interrater/Intrarater Reliability:

Internal Consistency:

Patients undergoing surgery for oral or oropharyngeal SCCA:

 

(Rogers S., Humphris G., Lowe D., Brown J., Vaughan E., 1998; n = 48, mean age (SD), 61 (12))

 

Subscale	Cronbach's alpha
Physical functioning	0.95
Role limitation, physical	0.92
Role limitation, mental	0.86
Social functioning	0.77
Mental health	0.78
Energy/Vitality	0.72
Pain	0.81
General health perception	0.79

 

Laryngeal cancer (Italian version):

 

(Mosconi P., Cifani S., Crispino S., Fossati R., Apolone G., 2000; n = 165, 64 (9.2), patients 0-262 months post-treatment)

 

Subscale	Cronbach's alpha
Physical functioning	0.88
Role limitation, physical	0.83
Role limitation, mental	0.84
Social functioning	0.91
Mental health	0.81
Energy/Vitality	0.81
Pain	0.85
General health perception	0.69

Criterion Validity (Predictive/Concurrent):

Patients within 2 years of diagnosis for head and neck cancer:

 

(Karvonen-Gutierrez C.A., Ronis D.L., Fowler K.E., Terrell J.E., Gruber S.B., Duffy S.A., 2008; n = 495)

• Predictive Validity:
  • When controlling for demographic, health behavior and clinical variables, QOL as measured by the SF-36, the PCS score is significantly associated with survival (hazard ratio 0.86, 95% CI 0.80-0.93).
  • For every 5-point increase in the PCS score, the risk of death decreased 0.14 times.

Construct Validity (Convergent/Discriminant):

Patients with cancer of the upper aero digestive tract:

 

(Chen A.Y., Frankowski R., Bishop-Leone J., et al., 2001)

 

Construct validity of the MD Anderson Dysphagia Index (MDADI) was determined through correlating the subscales of the SF-36 and MDADI. (Spearman correlation coefficient, greater than 0.60 - strong correlation, 0.40-0.60 - moderate to substantial, less than 0.40 - weak)

 

	MDADI Subscales
SF-36 Subscales	Global	Emotional	Functional	Physical
Physical functioning	0.29	0.36	0.31	0.40
Role - physical	0.31	0.33	0.37	0.38
Bodily Pain	0.21	0.23	0.24	0.26
General Health	0.21	0.33	0.28	0.32
Vitality/Energy	0.34	0.50	0.45	0.52
Social Functioning	0.44	0.50	0.45	0.51
Role - Emotional	0.34	0.40	0.42	0.43
Mental Health	0.27	0.30	0.29	0.34
PCS	0.25	0.30	0.29	0.34
MCS	0.44	0.54	0.51	0.54

 

Patients with head and neck cancer who underwent selective or modified radical neck dissection:

 

(Taylor R.J., Chepeha J.C., Teknos T.N., Bradford C.R., Sharma P.K., Terrell J.E., Hogikyan N.D., Wolf G.T., Chepeha D.B., 2002; n = 54, patients had a minimum postoperative convalescence of 11 months) 

 

Convergent validity of the Neck Dissection Impairment Index (NDII):

(Spearmen or Pearson not specified)

Subscale	Correlation to NDII	P-value
Physical functioning	0.50	<0.001
Role limitation, physical	0.60	0.001
Role limitation, mental	0.59	0.001
Social functioning	0.62	0.001
Mental health	0.56	0.001
Energy/Vitality	0.44	0.001
Pain	0.32	0.001
General health perception	0.55	0.001

 

Patients undergoing surgery for oral or oropharyngeal SCCA:

 

(Rogers S., Humphris G., Lowe D., Brown J., Vaughan E., 1998)

 

Correlation between SF-36 and University of Washington Hand and Neck Questionnaire:

Subscale	Pearson's Correlation
Physical functioning	0.61, P<0.001
Role limitation, physical	0.66, P<0.001
Role limitation, mental	0.47, P<0.01
Social functioning	0.54, P<0.001
Mental health	-0.08
Energy/Vitality	0.43, P<0.01
Pain	0.61, P<0.001
General health perception	0.42, P<0.01

 

(Rogers S.N., Lowe D., Brown J.S., Vaughan E.D., 1998)

• Spearman correlation coefficients:
  • SF-36 with European Organization for Research and Treatment of Cancer (EORTC): r = 0.83
  • SF-36 with University of Washington Head and Neck Disease-Specific Measure (UW-QOL): r = 0.80

Laryngeal cancer (Italian version):

 

(Mosconi P., Cifani S., Crispino S., Fossati R., Apolone G., 2000)

• Convergent Validity - within subscale coefficients all higher than 0.40
• Discriminant Validity - higher item-scale correlations found within the subscale than between the subscales

Content Validity:

Face Validity:

Floor/Ceiling Effects:

Patients undergoing surgery for oral or oropharyngeal SCCA:

 

(Rogers S., Humphris G., Lowe D., Brown J., Vaughan E., 1998)

• No floor or ceiling effects

Responsiveness:

Laryngeal cancer (Italian version):

 

(Mosconi P., Cifani S., Crispino S., Fossati R., Apolone G., 2000)

 

Subscale	Effect Size
Physical functioning	0.45
Role limitation, physical	0.78
Role limitation, mental	0.40
Social functioning	0.66
Mental health	0.29
Energy/Vitality	0.04
Pain	0.88
General health perception	0.74
Component Summary Scores
Physical	1.1
Mental	0.09

(reference: first level of treatment extent, 0.60 indicates an important magnitude of change)

Considerations:

Bibliography:

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